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# Since Our Last Issue ...
- URL: https://www.fdaweb.com/since-our-last-issue-29/
- Published: 2020-10-11T12:00:00.000Z
- Updated: 2026-09-14T16:32:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137433

**Mylan** has signed an agreement with the **Medicines Patent Pool** (MPP) to expand access to chronic hepatitis C medicines in developing countries. The agreement licenses Mylan to produce and market a generic version of **Bristol-Myers Squibb**’s Daklinza (daclatasvir) Tablets, 30 mg and 60 mg, for distribution in 112 low- and middle-income countries. Daclatasvir Tablets, 30 mg and 60 mg, are indicated for use with sofosbuvir, with or without ribavirin, for treating patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection in the U.S. and genotype 1, 3 and 4 in Europe. The license allows Mylan to develop fixed-dose combinations that offer the potential to treat all of the six major genotypes of HCV.

**Sun Pharma** has signed definitive agreements to acquire an 85% stake in Russia-based **JSC Biosintez** for $24 million. Sun would also assume a debt of about $36 million as part of the transaction. Biosintez focuses on the hospital segment, and it had annual revenues of about $52 million for 2015.

**Navidea Biopharmaceuticals** has entered into a definitive asset purchase agreement with **Cardinal Health** for Cardinal to purchase Navidea’s Lymphoseek product for lymphatic mapping, lymph node biopsy and diagnosing metastatic spread to lymph nodes. Navidea will receive $80 million at closing, plus the opportunity to earn up to $230 million more based on certain milestones through 2026.

**Edwards Lifesciences** has agreed to acquire **Valtech Cardio**, a privately held company based in Israel and developer of the Cardioband System for transcatheter repair of the mitral and tricuspid valves. The purchase price is $340 million in stock and cash. Prior to the transaction close, Valtech will spin off its early-stage transseptal mitral valve replacement technology program. Edwards will retain an option to acquire that program and its associated intellectual property.